Situation
Clinical trials establish the evidence base for prevention and treatment of disease and are critically important in low-income countries. This importance is threefold: there is the greatest potential for improving health in numerical terms, there is enormous potential gain from relatively simple interventions, and these areas have been under represented in clinical trials to date. Clinical trials in developing countries typically have endpoints that are severe disease outcomes or mortality. They more often involve children and are sponsored by not-for-profit organisations. There are also specific situations, such as disease outbreaks, including those with pandemic potential, in displaced populations, refugee camps and natural disasters, which merit more and better clinical trials to inform policy. These very specialist situations and environments need a research focus in order to identify highly practical and appropriate interpretation of guidelines and regulations to enable rapid and flexible trial implementation whilst maintaining the same degree of attention to ethical standards and to quality of processes and data as any international trial.

Background: Clinical Trials, the global perspective
It is becoming widely accepted that clinical trials have become overly cumbersome, expensive and burdened by administration. A recent meeting of clinical trials organisations (http://www.ctsu.ox.ac.uk/projects/sg) agreed that there has been a reduction in the number of non-commercial trials being conducted and that there is an overall need to revise how trials are planned, managed, regulated and audited to try and make them less daunting and more able to focus on answering the question that they are asking.

In order to improve and make trials easier we must observe and measure the current situation and also identify new methods, approaches and tools. In the US there is an initiative set up between the FDA and Duke University to lead a research programme into these issues (www.trialstransformation.org). However these activities are largely focussed on the US and Europe and it is important that developing countries take part in similar initiatives as in many respects the need is greater in these regions and there is a paucity of evidence into what the real issues and barriers to research are. We therefore propose highly novel and cross cutting research that will fill a clear gap.

Target: A body of evidence to guide and influence change and development
Clinical research teams often comment that trials are taking longer to set up, are costing more, require more contracts (adding further delay) and involve more people and organisations. It is this perception of increased administration and regulation that discourages would-be researchers from becoming investigators as the trial process is seen as being prohibitively expensive. However this has rarely been measured and this is especially true in the context of developing countries. 
If improvement and rationalisation is to occur then evidence and data are needed. In the same way that we would approach a trial for improving disease outcomes, we need to conduct basic research to inform and improve trial conduct. We need to understand the scale of the problem and characterise it so that we can identify targets for intervention. Thus we must examine clinical trial operations and collect observational data to allow for the identification, testing and validation of possible interventions that could improve their conduct.

Through this online network we intend to conduct studies that employ quantitative and qualitative research methods that through the mechanisms of participatory action research build a body of knowledge that can inform and guide improvement and development of clinical trial methods and tools specific to this setting, yet generally applicable to many others.

The approach of action research allows findings to be available as they are gathered and is a form of research where a group of people experiencing an issue take part in identifying the problem and finding solutions. Although novel and experimental in this setting this is a well established methodological approach which will also help foster a spirit of collaboration and open access. The research will provide a continuous feed to highlight issues and share ‘best practice’ solutions, using the cyclical action research theory. This website provides the ideal vehicle for such research and we invite any researcher who might be interested to get in touch